FDAFDA · Food and drugs·Recall number Z-0105-2015
Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A Intended for: " Monitoring the physiological parameters of pregnant women " Non-invasive monitoring of fetal heart rates and movements.
Published October 29, 2014 · Recall initiated: October 3, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems, Inc.
- Distributor
- Worldwide Distribution-USA (nationwide) and the countries of AUSTRALIA AUSTRIA BAHRAIN BELGIUM CHINA COLOMBIA CZECH REPUBLIC DENMARK FINLAND FRANCE GERMANY HONG KONG INDIA IRELAND ISRAEL ITALY JAPAN KAZAKHSTAN NETHERLANDS NEW ZEALAND NICARAGUA NIGERIA NORWAY OMAN POLAND ROMANIA RUSSIA SINGAPORE SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UKRAINE and UNITED KINGDOM.
- Lot
- software revision J.30.58:
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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